Legal Issues Affecting Generic Drugs

In a Today’s General Counsel article, Duane Morris attorneys look at some major legal issues for an industry that fills more than 86 percent of the prescriptions dispensed in the United States. Intellectual property tops the list. The Leahy-Smith America Invents Act, passed in 2011, effected major changes to U.S. patent law, including creating new procedures for non-patentees to challenge a patent’s validity. Among these new procedures, inter partes review (IPR) has emerged as a useful strategic tool for generic pharmaceutical companies to supplement litigation stemming from existing law, although for generic filers IPRs also have some downsides. Other issues that will affect the generics industry include possible new labeling requirements that could have a significant effect on future exposure to product liability suits.